EDAN recalled 395 units of its Central Monitoring System on October 24, 2025, due to potential cybersecurity risks. The affected models include MFM-CNS and MFM-CNS Lite, which manage critical fetal and maternal health data. Healthcare providers must stop using the devices immediately and follow the recall instructions.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Edan Diagnostics or your healthcare provider for instructions. Notification method: Letter
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The recalled models are MFM-CNS and MFM-CNS Lite. They were distributed worldwide, including in California, Kentucky, Puerto Rico, Florida, Connecticut, Illinois, Pennsylvania, Rhode Island, North Carolina, New York, Louisiana, Texas, Michigan, and Mexico.
The recall stems from an FDA It Has Come to Our Attention Letter regarding potential cybersecurity issues. These vulnerabilities could compromise patient data security.
Stop using the device immediately. Contact Edan Diagnostics or your healthcare provider for further instructions and follow the recall instructions provided.
For more information, contact Edan Diagnostics at their official website or through the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1151-2026.
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